NCT02384031

Brief Summary

Post-dural puncture headache (PDPH) is the most common complication following lumbar puncture (LP). The frequency varies widely depending on a number of factors, among which patient characteristics, case ascertainment, gauge and type of needle used are of significant importance. In 2001, Strupp et al. showed that over 12 % of 115 patients who were subjected to diagnostic lumbar puncture with a 22 gg (0.7 mm) atraumatic needle suffered post-dural puncture headache, while over 24 % of 115 who were given a lumbar puncture with a 22 gg traumatic needle suffered a headache. This finding provided the basis for an American recommendation to use a 22 gg atraumatic needle for diagnostic lumbar puncture. A later study with 58 patients has shown an even greater difference (36 % versus 3 % post-dural puncture headache) when an atraumatic needle is used. Despite these findings, European Neurologist continue to hold on to the cutting needle. Here the investigators propose a prospective randomized study design with double masking; neither patient nor evaluator of PDPH aware of the needle design used, and with an active ascertainment of the occurrence of PDPH in accordance with updated headache classification guidelines. The investigators also intend to investigate whether specific neuroinflammatory substances and metabolites (different outcome variables) in the cerebrospinal fluid (CSF) will affect the explanatory variable.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

7.2 years

First QC Date

February 27, 2015

Last Update Submit

April 5, 2019

Conditions

Post-dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

  • Post-dural puncture headache (PDPH)

    At day 7 post LP

Secondary Outcomes (3)

  • Levels of neuropeptides in CSF

    During lumbar puncture

  • Levels of metabolites in CSF

    During lumbar puncture

  • Levels of inflammatory mediators in CSF

    During lumbar puncture

Study Arms (2)

Traumatic group

ACTIVE COMPARATOR

Traumatic needle

Device: Traumatic needle

Atraumatic group

ACTIVE COMPARATOR

Atraumatic needle

Device: Atraumatic needle

Interventions

Traumatic needleDEVICE

Lumbar puncture is performed with a traumatic needle

Also known as: Spinocan® (Quincke) 22Gx3.5"
Traumatic group
Atraumatic needleDEVICE

Lumbar puncture is performed with an atraumatic needle

Also known as: Pencan® (Sprotte) 22Gx3.5"
Atraumatic group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Patients at Department of Neurology, Nordland Hospital Trust in Bodø, scheduled for diagnostic LP

You may not qualify if:

  • Dementia
  • Non-compliance or coma
  • Local skin infections over proposed puncture site
  • Suspicion of raised intracranial pressure due to neurological or radiological findings
  • Bleeding diathesis (thrombocytopenia \<50 x 109/L) or ongoing anticoagulant therapy
  • Major spinal column deformities
  • Procedural complications whereby needle type or size change is a requisite
  • Recent LP (\< 7 days)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Neurology, NLSH HF

Bodø, 8092, Norway

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Karl Alstadhaug, MD, PhD

    Nordlandssykehuset HF

    PRINCIPAL INVESTIGATOR

  • Francis Odeh, MD, PhD

    Nordlandssykehuset HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 10, 2015

Study Start

February 1, 2012

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations

NO(1)